Single-use lancet sensor assembly and meter

ABSTRACT

A single-use lancet cartridge for inserting into a multi-use lancet driver assembly of a meter housing includes an elongated lancet housing with an open end, a lancet within the lancet housing and movable between a retracted and resting orientation to a piercing orientation through the open end, and a re-use prevention component that is a rotated drive wing incorporated within the lancet cartridge and oriented to cooperatively engage with a driver piston of the multi-use lancet driver assembly only one time thereby preventing the lancet from being moved into a piercing orientation a second time.

This application is a Divisional application of Ser. No. 12/187,416,filed on Aug. 7, 2008.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to a lancet device.Particularly, the present invention relates to a single use lancetdevice that prevents re-use of the lancet.

2. Description of the Prior Art

Lancets are well-known devices commonly used in the medical field tomake small punctures in a patient's skin in order to obtain samples ofblood. They are utilized in hospitals, other medical facilities and byprivate individuals such as diabetics for testing droplets of blood forvarious analytes. Typically, lancets are used only once in order toreduce the risk of HIV, hepatitis and other bloodborne diseases. Theneedle of these devices is driven into the patient's skin by a smallspring that is cocked by a technician or user prior to use. The needleis covered with a protective, safety cap that is removed before use. Thesafety cap keeps the end of the lancet sterile and is typically used asa kind of pushrod for arming the device. After arming the device, thesafety cap is removed exposing the needle and the lancet is ready foruse.

There are a variety of lancet devices that are available for utilizationby patients and/or practitioners in a variety of differentcircumstances. One variety is configured for multiple and/or repeateduses. This variety typically includes a lancet injector that projects alancet toward the skin of a patient that is pushed by the user. Morecommonly, the lancet device effectively encases and fires the lancetinto the patient's skin in order to puncture in an accurate,standardized and consistent manner. The lancet injector may also beprovided with an adaptor cap to control and adjust the depth ofpenetration of the needle of the lancet.

Another variety is configured for single use where the entire device isdiscarded after use. Typically, these devices include a housing thatcontains and directs or drives a piercing tip into the patient's skinand then is discarded along with the used lancet. Such devices areeffective for achieving the piercing of the skin required for effectiveoperation. These single-use, disposable devices, however, typically donot incorporate a large number of safety features to ensure safe use anddisposal of the device. A major disadvantage of such devices is thatthey can be inadvertently re-used. The configuration of these devices issuch that a user can re-cock the device and allow for subsequent andinappropriate use of a contaminated lancet.

There have been some devices developed that affirmatively prevent re-useof a single use lancet. U.S. Pat. No. 5,423,847 (1995, Strong et al.)discloses a safe lancet injector. The safe lancet injector for use witha lancet and an isolating platform to obtain blood samples fordiagnostic purposes. The lancet injector uses two elastomeric bands topush the lancet forward and to rapidly withdraw the needle from theskin. It further includes an interlocking mechanism that completelyprecludes a lancet from being used more than once, which causes the usedlancet to be ejected before cocking/arming the lancet injector can beperformed.

U.S. Pat. No. 6,168,606 (2001, Levin et al.) discloses a single-use,spring-driven lancet device. The device is precocked during assembly sothat the user needs only to remove the safety cap prior to use. A thinplastic fiber connection between the pull-tab and the needle safety capprevents any compressive force from being applied to the drive spring,which prevents recocking/re-arming of the device.

U.S. Pat. No. 6,514,270 (2003, Schraga) discloses a single use lancetdevice having a housing, a lancet with a piercing tip movably disposedin the housing and structured to move between a cocked orientation and apiercing orientation, and a driving assembly structured to move thelancet into the piercing orientation. A retention member and anengagement hub are provided and structured to cooperatively engage withone another when the lancet is disposed into the cocked orientationuntil released by an actuation assembly. The actuation assembly isstructured to move between an actuated and an un-actuated orientation.Movement of the actuation member into the actuated orientation releasesthe retention member and the engagement hub from their cooperativeengagement with one another resulting in the movement of the lancet intothe piercing orientation. A restrictor assembly prevents the actuationassembly from moving out of the actuated orientation and preventsre-firing of the lancet using the actuation assembly.

These devices, however, are only lancet devices and must be used withseparate test strips for making an analyte determination on the sampleof blood produced by the lancet device.

There has also been developed integrated lancet and sensor devices thatcombine the lancet and test strip into a single package. Theseintegrated devices are typically used with a lancet injector where theintegrated lancet and test strip is removed from the lancet injector andconnected to a meter after acquisition by the test strip of the bloodsample produced by the lancet, or used with a meter with built-in lancetinjector.

One such integrated device is disclosed in U.S. Patent ApplicationPublication 2007/0149897 by Ghesquiere et al. The device is anintegrated lancet and testing striplet for measuring a body analytelevel in a health care regimen that includes a lancet needle and ananalyte sensor coupled together. A lancet body includes a sensorreceiving end and a lancet end. The lancet needle is coupled with andprotruding from the lancet end. The sensor is coupled to the sensorreceiving end of the lancet body. The integrated device is positionedwithin a rotating cradle and, during the assay or after completion ofthe assay, the cradle is rotated by mechanical transmission to positionthe lancet for re-attaching the protective cover to the used lancet ofthe lancet-test strip combination.

U.S. Patent Application Publication 2006/0020228 (2006, Fowler et al.)discloses an integrated lancet and test strip. The assembly includes alancet disposed within a lancet enclosure where the lancet moves betweena retracted position and an extended position out of a needle end of thelancet enclosure, and an elongated test strip having a sample receivingend disposed at the needle end of the lancet enclosure. After piercingthe skin, the lancet is retracted into the lancet enclosure so that itis not exposed to prevent accidental piercing.

A major disadvantage of these integrated lancet and test strip devicesis the lack of a safety mechanism to prevent re-firing/re-use of a usedintegrated device. Prior art devices can be inadvertently re-fired bysimply re-cocking the firing mechanism, which can lead to inadvertentand accidental skin punctures with a used lancet.

Therefore, what is needed is lancet device that is a single use lancetwith a safety mechanism to prevent re-use. What is also needed is anintegrated lancet and test strip device where the lancet portion cannotbe re-fired/re-used.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a lancet device thatcan only be used one time. It is another object of the present inventionto provide an integrated lancet sensor system that cannot beaccidentally re-used.

The present invention achieves these and other objectives by providing asafety lancet system that includes at least a single-use lancet assemblywith a re-use prevention component and a separate multi-use lancetdriver assembly. The single-use lancet assembly includes a re-useprevention component. The single-use lancet assembly with the re-useprevention component is operably combined with the multi-use lancetdriver assembly where the re-use prevention component of the single-uselancet assembly is configured to prevent the lancet from extending outof the lancet assembly and into a piercing orientation after an initialuse. Particularly, the re-use prevention component interacts with alancet driver piston of the lancet driver assembly. The lancet driverassembly is reusable while the lancet assembly is a one-time use device.The lancet driver assembly is configured for engaging a lancet of thelancet assembly and, when activated, to extend the lancet into apiercing orientation before disengaging the lancet. The multi-use lancetdriver assembly further includes an activating trigger that iscooperatively connected to the driver piston when the driver piston isin a cocked or armed orientation.

In one embodiment of the present invention, the single-use lancetassembly of the safety lancet system includes a cocking tab that engagesthe lancet driver piston of the lancet driver assembly. The cocking tabarms the lancet driver piston when the single-use lancet assembly isoperably combined with the multi-use lancet driver assembly. The cockingtab is removed from the single-use lancet assembly after arming thelancet driver piston. Optionally, the cocking tab is integrallyconnected to a needle safety cap that maintains the needle of the lancetin a sterile condition until use. When the needle safety cap is removedfrom the needle of the single-use lancet assembly, the cocking tab isalso removed simultaneously. It is the cocking tab of the single-uselancet assembly that arms the lancet driver assembly. Once the cockingtab is removed, it cannot be re-assembled into the single-use lancetassembly. Without the cocking tab, any re-combining of the used lancetassembly with the multi-use lancet driver assembly will fail to arm thedriver piston since the piston interface surface of the cocking tab ismissing. Consequently, the single-use lancet assembly cannot be re-usedand any inadvertent attempt to re-use a previously used lancet assemblyis prevented.

In another embodiment of the present invention, the single-use lancetassembly of the safety lancet system includes a rotating drive wing thatis engaged by the lancet driver piston of the lancet driver assemblyupon activation after the single-use lancet assembly is operablycombined with the multi-use lancet driver assembly. The lancet driverpiston also includes a drive wing pawl that engages the rotating drivewing upon the return of the lancet driver piston after the lancet hasachieved its piercing orientation. The drive wing pawl rotates the drivewing into a non-engageable orientation during the return of the lancetdriver piston to its resting orientation.

In another embodiment of the present invention the single-use lancetassembly includes an anti-rotation wing stop that prevents the rotatingdrive wing from rotating into a non-engageable orientation before theinitial use of the lancet assembly.

In still another embodiment of the present invention, the lancet driverpiston of the multi-use lancet driver assembly includes a deflectabledrive wing pawl. The drive wing pawl has a wing rotating surface that isengageable with the rotatable drive wing after the driver piston hasmoved the lancet into a piercing orientation. The wing rotating surfacecontacts the rotatable drive wing and rotates the rotatable drive winginto a non-engageable orientation during the driver piston's return tothe resting orientation.

In another embodiment of the present invention, the multi-use lancetdriver assembly is housed within a system enclosure and includes alancet cartridge lock. The lancet cartridge lock has an elongated andbiasing member with a locking tab extending laterally from the biasingmember. The locking tab is situated for cooperative and biasingengagement with a notch in the bottom of the single-use lancetcartridge, preferably along the central longitudinal axis of the lancetcartridge, when a lancet cartridge is inserted into a lancet cartridgereceiving port of the system enclosure.

In another embodiment of the present invention, the multi-use lancetdriver assembly includes an ejector member. The ejector member has anejector body with a tab engaging surface, a lancet cartridge ejectingsurface and a discharge button laterally and integrally connected to theejector body. The discharge button is disposed outside of the systemenclosure and slidably moves to eject the lancet cartridge. The tabengaging surface is positioned to engage the locking tab before thelancet cartridge ejecting surface engages the lancet cartridge when thedischarge button is actuated.

In yet another embodiment of the present invention, the multi-use lancetdriver assembly includes a depth setting gauge that has a driver pistonengaging surface, which is non-planar, situated within the systemenclosure for cooperative engagement with a portion of the driver pistonof the multi-use lancet driver assembly. An outer surface portion of thedepth setting gauge extends outside of the system enclosure to allowselecting a predefined depth penetration of the lancet into thespecimen.

In still another embodiment of the present invention, the multi-uselancet driver assembly includes an arming member. The arming member hasan arming member body and a cocking button laterally and integrallyconnected to the arming member body. The cocking button is disposedoutside of the system enclosure to slidably move the drive piston into acocked orientation.

In another embodiment of the present invention, the multi-use lancetdriver assembly includes an electronic measuring module disposed withinthe system enclosure for measuring the concentration of an analyte whenthe lancet cartridge incorporates a single-use sensor strip integrallyconnected to the lancet cartridge. The electronic measuring module has asensor strip interface for electronically coupling to the sensor strip.

In a further embodiment of the present invention, the multi-use lancetdriver assembly includes a scanner module within the system enclosurethat is electronically coupled to the electronic measuring module. Thescanner module scans a unique patient bar code that allows the analytemeasurement to be associated with the patient possessing the patient barcode.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is perspective view of one embodiment of the safety lancet andsensor assembly of the present invention.

FIG. 2 is an exploded, perspective view of the embodiment in FIG. 1showing the lancet housing, the lancet, the sensor strip, and the re-useprevention component.

FIG. 3 is a top view of the embodiment in FIG. 1.

FIG. 4 is a side view of the embodiment in FIG. 1 showing the housingretention notch and the re-use prevention component connected to thelancet.

FIG. 5 is an enlarged, perspective view of the re-use preventioncomponent in FIGS. 1 and 2.

FIG. 6 is a perspective view of another embodiment of the single-uselancet and sensor assembly of the present invention.

FIG. 7 an exploded, perspective view of the embodiment in FIG. 6 showingthe lancet housing, the lancet, the re-use prevention component that isa rotating wing, and the sensor strip.

FIG. 8 is a top view of the embodiment in FIG. 6.

FIG. 9 is an enlarged, bottom, perspective view of the lancet androtating wing in FIG. 8.

FIG. 10 is an exploded, perspective view of the lancet driver and pawlused for engaging the rotating wing of the lancet.

FIG. 11 is a side view of the assembled lancet driver and pawl in FIG.10.

FIG. 12 is a perspective view of the lancet cartridge and lancet drivershowing the pawl engaging the rotating wing after driving the lancet toits piercing orientation.

FIG. 13 is a front perspective view of the single-use lancet cartridgeand meter showing the lancet cartridge mounted into a meter housing.

FIG. 14 is a rear perspective view of the single-use lancet cartridgeand meter showing the scanner window coupled to the meter housing.

FIG. 15 is a top view of another embodiment of a meter for use with thecocking tab safety lancet.

FIG. 16 is a perspective view of one embodiment of a meter for use withthe rotating wing safety lancet.

FIG. 16A is a top view of FIG. 16.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The preferred embodiment(s) of the present invention is illustrated inFIGS. 1-16. FIG. 1 illustrates one embodiment of the single-use lancetcartridge 10 of the present invention for use with a multi-use lancetdriver assembly and meter. Lancet cartridge 10 incorporates a re-useprevention component 70 that cooperates and engages with a driver pistonsimilar to the one shown in FIGS. 10-12. Re-use prevention component 70is removably coupled to a lancet housing 20 as the top component in thelancet cartridge 10 with a portion extending beyond lancet housing end21. FIG. 2 is an expanded view of lancet cartridge 10 showing thevarious components that are assembled to form lancet cartridge 10.Lancet cartridge 10 includes a lancet housing 20, a lancet 40, a sensortest strip 60, and re-use prevention component 70.

Lancet housing 20 includes a housing recess 23 that is configured toreceive and contain lancet 40 when lancet cartridge 10 is in a staticstate. Lancet housing 20 has a housing open end 21 through which lancet40 protrudes and retracts during use and a housing closed end 22. Lancet40 has a first drive wing 44 and an optional second drive wing 45 thatextend out the sides of lancet housing 20. Lancet housing 20 may be madeof metal or a plastic material such as, for example, polyvinyl chloride,polycarbonate, polysulfone, nylon, polyurethane, cellulose nitrate,cellulose propionate, cellulose acetate, cellulose acetate butyrate,polyester, acrylic, and polystyrene.

Lancet housing 20 includes a housing recess 23, a first side opening 24,a second side opening 25 and an optional first and second wing guards26, 27. When optional first and second wing guards 26, 27 areincorporated into lancet housing 20, there are formed driver pistonchannels 28, 29 between first wing guards 26, 27 and the sides 30, 31 oflancet housing 20, respectively. First and second side openings 24, 25are sufficiently elongated to allow the lancet 40 to move between aretracted and resting orientation and exposed piercing orientation.

Lancet 40 includes a lancet body 42 having first and second drive wings44, 45, a biasing member 46, a lancet needle 48 (shown in FIGS. 9 and12), and an optional needle safety cap 50. Optional needle safety cap 50includes a tab capturing opening 52. Biasing member 46 is directlyconnected to lancet body 42 on one end and includes an anchoringcomponent 48 at the opposite end. Anchoring component 48 preferablyincludes a slot 49 that receives a retaining flange 35 of lancet housing20. Anchoring component 48 fixes one end of lancet 40 so that biasingmember 46 functions as intended, which is to pull the lancet body 42 andlancet needle 48 back into a retracted orientation within lancet housing20 after having been moved to exposed piercing orientation by the driverpiston.

Sensor test strip 60 is a disposable sensor strip capable of measuringthe concentration of a predefined analyte in a liquid sample. An exampleof such a sensor test strip is a disposable glucose test strip formeasuring blood glucose. However, disposable strips designed to measureother analytes may also be incorporated into lancet cartridge 10.

Re-use prevention component 70 in this embodiment is a removable,elongated, piston cocking tab 71 (shown in FIG. 2) having at least onedriver piston engageable surface 72 located at a first tab end 73 and aneedle cap interlocking mechanism 74 at or near a second tab end 75.Piston cocking tab 71 may optionally include an alignment notch 76,which may cooperate with an alignment tab within the meter housing towhich the lancet cartridge 10 is coupled.

Turning now to FIG. 3, there is illustrated a top view of lancetcartridge 10 of the embodiment of FIG. 1. As is more clearly shown,first and second drive wings 44, 45 extend outwardly and perpendicularlyfrom housing sides 30, 31 (shown in FIG. 2) into drive channels 28, 29.It is important to note that lancet cartridge 10 is unusable without ameter housing that incorporates a lancet driver mechanism to drivelancet 40 (shown in FIG. 2) from a retracted orientation to exposedpiercing orientation.

FIG. 4 shows a side view of lancet cartridge 10. Referring back to FIG.2, piston cocking tab 71 includes a piston flange 77 that extendslaterally and downwardly from a first side edge 71 a into piston channel28 behind first drive wing 44 and closer to housing closed end 22.Piston flange 77 includes driver piston engageable surface 72.Optionally, piston cocking tab 71 may include a second piston flange 78that extends laterally and downwardly from a second side edge 71 b shownin FIG. 5. Needle cap interlocking mechanism 74 extends through tabcapture opening 52 of needle safety cap 50 and interlocks piston cockingtab 71 with needle safety cap 50. When lancet cartridge 10 is insertedinto a meter housing having an appropriate lancet driver mechanism, thedriver piston engageable surface 72 engages the lancet driver piston andpushes the lancet driver piston into an armed position. When needlesafety cap 50 is removed from lancet cartridge 10 after lancet cartridge10 is inserted into the meter housing and the piston cocking tab 71 hasarmed the lancet driver piston within the meter housing, piston cockingtab 71 is also simultaneously removed from lancet cartridge 10. Theremoval of piston cocking tab 71 from lancet cartridge 10 effectivelyremoves the cocking mechanism that arms the lancet driver pistonsituated in the meter housing.

After lancet cartridge 10 is used to lance a specimen, lancet cartridge10 no longer has the necessary cocking tab 71 to re-arm the lancetdriver piston. If the used lancet cartridge 10 is removed from the meterand then reinserted, there is no piston engageable surface 72 to engagethe lancet driver piston and to drive the piston into the armedposition. Where the lancet driver piston cannot be re-armed with apreviously used lancet cartridge 10, it is not possible to reuse apreviously used lancet cartridge 10 for lancing the same or anotherspecimen to obtain a test sample. Thus, the lancet cartridge 10 is trulya single-use lancet cartridge.

Another feature that is more clearly shown in FIG. 4 is the lancetcartridge retainer notch 36. Cartridge retainer notch 36 cooperates witha locking mechanism within the meter housing to retain lancet cartridge10 coupled with the meter housing until it is desired to remove lancetcartridge 10 from the meter housing.

Turning now to FIG. 5, there is illustrated an enlarged perspective viewof the re-use prevention component 70. As previously disclosed, thecocking tab 71 includes the needle cap interlocking mechanism 74, whichis a flange that is inserted into the tab capture opening 52 of needlesafety cap 50, adjacent the second tab end 75, and the piston flange 77that extends laterally and downwardly from cocking tab 71 at the firsttab end 73 with the piston engageable surface 72.

FIG. 6 illustrates another embodiment of single-use lancet cartridge 10for use with a multi-use lancet driver assembly and meter. In thisembodiment, lancet cartridge 100 incorporates a re-use preventioncomponent 170 that cooperates and engages with a driver piston shown inFIGS. 10-12. Unlike the previously disclosed embodiment, only the needlesafety cap 150 extends out of the open end 121 of lancet housing 120.FIG. 7 is an expanded view of lancet cartridge 100 showing the variouscomponents that are assembled to form lancet cartridge 100. Lancetcartridge 100 includes a lancet housing 120, a lancet 140, a sensor teststrip 160, and re-use prevention component 170. Like in the previouslydisclosed embodiment, lancet housing 120 includes a housing recess 123that is configured to receive and contain lancet 140 when lancetcartridge 100 is in a static state. Lancet housing 120 has a housingopen end 121 through which lancet 140 protrudes and retracts during useand a housing closed end 122.

Lancet housing 120 also includes a first side opening 124, an optionalsecond side opening 125 and an optional first and second wing guards126, 127. When optional first and second wing guards 126, 127 areincorporated into lancet housing 120, there are formed driver pistonchannels 128, 129 between first wing guards 126, 127 and the sides 130,131 of lancet housing 120, respectively. First and second side openings124, 125 are sufficiently elongated to allow the lancet 140 to movebetween a retracted and resting orientation and a piercing orientation.

Lancet 140 includes a lancet body 142 having a rotatable drive wingmount 143 (not shown) on one side of lancet body 142, a rotatable drivewing stop 144, a biasing member 146, a lancet needle 148 (shown in FIGS.9 and 12), and an optional needle safety cap 150. Biasing member 146 isdirectly connected to lancet body 142 on one end and includes ananchoring component 148 at the opposite end. Anchoring component 148preferably includes a slot 149 that receives a retaining flange 135 oflancet housing 120. Anchoring component 148 fixes one end of lancet 140so that biasing member 146 functions as intended, which is to pull thelancet body 142 and lancet needle 148 back into a retracted and restingorientation within lancet housing 120 after having been moved to apiercing orientation by the driver piston.

Sensor strip 160 incorporated in lancet cartridge 100 is the same orsimilar to sensor strip 60 previously disclosed.

Re-use prevention component 170 in this embodiment is a rotatable drivewing 172 that is rotatably mounted onto lancet 140 by way of the drivewing mount 143. Rotatable drive wing 172 includes a first drive wingportion 174, a second drive wing portion 176 and a middle drive wingportion 178 that directly connects to first and second drive wingportions 174, 176. Middle drive wing portion 178 is rotatably mounted torotatable wing mount 143 of lancet body 142. First drive wing portion174 extends out through a first side opening 124 and second drive wingportion 176 is positioned to be engageable with drive wing stop 144. Itshould be understood that second drive wing portion 176 may optionallyextend sufficiently from middle drive wing portion 178 to also extendout through the optional second side opening 125 of lancet housing 120.

FIG. 8 illustrates a top view of lancet cartridge 100. As more clearlyshown, first and second drive wing portions 174, 176 extend outwardlyand perpendicularly from housing sides 130, 131 (shown in FIG. 7) andinto drive channels 128, 129. As with the prior embodiment, thisembodiment of lancet cartridge 100 is also unusable without a meterhousing that incorporates a lancet driver mechanism to drive lancet 140from a retracted orientation to a piercing orientation.

FIG. 9 shows an enlarged, perspective, bottom view of lancet 140 withrotatable drive wing 170 mounted thereon. Rotatable drive wing 170 isrotatably mounted onto rotatable drive wing mount 143 with second wingportion 176 in contact with drive wing stop 144. Drive wing stop 144prevents rotatable drive wing 170 from rotating in the direction ofarrow 200 so that the first and second drive wing portions 174, 176extend approximately perpendicularly from lancet body 142 in order topresent the drive wing portions 174, 176 in proper position for contactfrom the lancet driver piston when lancet cartridge 100 is inserted intothe meter housing.

In order for the re-use prevention component 170 in this embodiment tofunction as desired, lancet driver piston must incorporate a componentto interact with rotatable drive wing 170. FIGS. 10 and 11 illustrateone embodiment of a lancet driver piston 180 for use with lancetcartridge 100. Driver piston 180 includes a piston body 181 having ends183, 185 and a drive wing piston surface 182 at end 183, a triggerrelease stop 184, a wing pawl 190 and a pawl mount 186. Wing pawl 190 isrotatably mounted on pawl mount 186 with a pawl spring (not shown) toprovide a limited range of motion indicated by arrow 210. Pawl 190includes a wing engageable portion 192 that includes a wing deflectorsurface 194 and a wing rotating surface 196. Wing engageable portion 192of pawl 190 extends beyond drive wing piston surface 182 a sufficientdistance such that first drive wing portion 174 lies between wingrotating surface 196 and drive wing piston surface 182 when lancetdriver piston 180 is fired from an armed position to move the lancetneedle and body 141, 142, respectively, from the retracted and restingorientation to the piercing orientation after lancet cartridge 100 isloaded into a meter housing containing lancet driver piston 180. Duringthe firing or activating process, wing deflector surface 194 contactsfirst wing portion 174. Because wing stop 144 prevents rotatable drivewing 172 from rotating, pawl 190 is deflected below first wing portion174 and until shortly before drive wing piston surface 182 contactsfirst wing portion 174. Upon return of driver piston 180 after drivinglancet needle 141 to its piercing orientation, wing rotating surface 196of pawl 190 engages first wing portion 174 and rotates rotatable drivewing 172 to position first drive wing portion 174 within lancet housing120 so that first drive wing portion 174 no longer extends out of lancethousing 120 and no longer presents a surface upon which drive wingpiston surface 182 can engage. Due to the rotation of drive wing 172,re-arming and firing/activating of lancet driver piston 180 fails todrive lancet needle 141 and lancet body 142 into a piercing orientationafter the first use. FIG. 12 illustrates wing rotating surface 196 ofpawl 190 rotating rotatable drive wing 172 during the return of lancetdriver piston 180 after having driven lancet needle 141 to its piercingorientation.

FIG. 13 is a front, perspective view of a portable meter housing 300 andlancet cartridge 10. Meter housing 300 includes display 330, anactivating trigger 310, a cartridge ejector 320, a control panel 340, acartridge port 350, and a scanner 360. Lancet cartridge 10, as shown,includes the re-use prevention component 70 that is the piston cockingtab 71. Because piston cocking tab 71 is included, meter housing 300does not include an arming mechanism for arming the lancet driver piston80 contained within meter housing 300 since the piston cocking tab 71arms lancet driver piston 80 when lancet cartridge 10 is inserted intocartridge port 350.

FIG. 14 shows a rear, perspective view of the meter housing 300illustrated in FIG. 13. Scanner 360 includes a scanner window 362 forscanning a bar code that may contain patient information. Meter housing300 includes an electronic measuring module containing at least aprocessor and memory for data storage, a scanner module, and a powermodule. Meter housing 300 may optionally include a charging module, adata transmission module, a data port, etc.

FIG. 15 illustrates a top view of the inside of meter housing 300showing only the lancet driver piston 180 and the cartridge ejector 320for clarity. Lancet driver piston 180 includes a plurality of biasingcomponents 198 such as springs to provide the means for driving thelancet driver piston 180 from the armed position to the piercingorientation and back to the retracted/resting orientation. Cartridgeejector 320 includes a cartridge release arm 324 that engages acartridge lock member 500 having a cartridge lock 502 that is positionedwithin the cartridge slot 36 previously shown in FIG. 4 when lancetcartridge 10 is inserted into meter housing 300, and a member releasesurface 504 that is also engaged by cartridge release arm 324. Cartridgelock member 500 is an elongated, resilient member with enoughflexibility to be moved laterally by cartridge release arm 324 but stiffenough to lock and hold lancet cartridge 10 or 100, as the case may be.Cartridge release arm 324 serves two purposes. It engages and moves thecartridge lock out of the cartridge slot 36 while nearly simultaneouslyejecting the lancet cartridge 10 out of meter housing 300. Cartridgeejector 320 also includes a plurality of biasing components 326.Noticeably missing from this embodiment of meter housing 300 is a lancetdriver piston arming component and a piercing depth gauge.

Turning not to FIG. 16, there is illustrated an open, perspective viewof meter housing 300 for use with lancet cartridge 100. In thisembodiment, meter housing 300 includes the multi-use lancet driverpiston 180, the cartridge ejector 320, a piercing depth control 400, anda lancet piston arming component 410. Cartridge ejector 320 includes anejector body 322 with cartridge release arm 324 having a tab engagingsurface 325 and a lancet cartridge ejector surface 326, and an ejectorbutton 328 integrally connected to ejector body 322. Lancet pistonarming component 410 has an arming member body 411 with a cocking button412 that is laterally and integrally connected to arming member body411. When cocking button 412 is activated by the user, arming component410 slidably engages an arming component end 413 with a portion ofdriver piston end 185 of the lancet driver piston 180, which moveslancet driver piston 180 into an armed position. Arming component end413 also acts as a driver piston stop that arrests the forward movementof lancet driver piston 180 toward the piercing orientation, which inturn controls the forward movement of the lancet needle 141 to thepiercing orientation. Arming component 410 also includes a piercingdepth end 414 that cooperates with piercing depth control 400. Piercingdepth control 400 is configured to variably adjust the piercing depth ofthe lancet needle 141 into the specimen and is manually controlled by auser. Piercing depth control 400 is an adjusting wheel that includes anarcuate surface 402 having a variable radius relative to a wheel axis401 that engages the piercing depth end 414 of arming component 410.Piercing depth control 400 also includes a detent engaging structure 404that cooperates with a fixed detent (not shown) of the meter housing300. Detent engaging structure 404 has indentations for receiving thedetent. The indentations represent pre-determined settings for thepiercing depth of the lancet needle 141 and coincide with specificlocations of the arcuate surface 402. An outer surface portion 406 ofpiercing depth control 400 extends outside of the meter housing 300 formanipulation by the user. FIG. 16A is a top view of FIG. 16 to moreclearly show the various components of piercing depth control 400,arming component 410, and cartridge ejector 320.

To use the lancet cartridge 10 having a piston cocking tab 71, lancetcartridge 10 is inserted into a meter housing 300 configured for usewith lancet cartridge 10. The process of inserting lancet cartridge 10into meter housing 300 causes piston engageable surface 72 of the pistoncocking tab 71 to engage and push the lancet driver piston within themeter housing 300 into an armed position. After removing the needlesafety cap 50, which simultaneously removes piston cocking tab 71 fromlancet cartridge 10, lancet cartridge 10 is ready for its single use.Because the piston cocking tab 71 is simultaneously removed from thelancet cartridge 10 when the needle safety cap 50 is removed, themechanism to arm the lancet driver piston is also removed. Thus,subsequent use of the lancet cartridge to pierce another or the samespecimen is defeated.

To use the lancet cartridge 100 having a rotatable drive wing 171,lancet cartridge 100 is inserted into a meter housing 300 configured foruse with lancet cartridge 100. Either before or after lancet cartridge100 is inserted into meter housing 300, lancet driver piston 180 isarmed by the user cocking the lancet driver piston using the lancetpiston arming component 410. Lancet piston arming component 410 isslidably moved rearwardly pushing lancet driver piston 180 into an armedposition until the trigger release stop 184 is engaged by triggerrelease 310. After removing the needle safety cap 150, lancet cartridge100 is ready for its single use. Upon activating the armed lancet driverpiston 180 by pressing the trigger 310, lancet driver piston 180 movestowards the first drive wing portion 174 of the rotatable drive wing172. During this movement, the pawl deflector surface 194 of pawl 190contacts first drive wing portion 174 and because a drive wing stop 144on lancet body 142 prevents the rotatable drive wing 170 from rotatingdue to the impact of the pawl deflector surface 194 with first drivewing portion 174, pawl 190 is deflected below first drive wing portion174 and automatically returns to its non-deflected position just beforedrive wing piston surface 182 engages first drive wing portion 174. Thelancet driver piston 180 then impacts first drive wing portion 174 andcontinues to the piercing orientation. Subsequent to reaching thepiercing orientation, wing rotating surface 196 of pawl 190 engagesfirst wing portion 174 and rotates rotatable drive wing 172 to positionfirst drive wing portion 174 within lancet housing 120 so that firstdrive wing portion 174 no longer extends out of lancet housing 120 andno longer presents a surface upon which drive wing piston surface 182can engage. The rotation of drive wing 172 into the lancet housing 120effectively removes the presentation of a contact surface to the lancetdriver piston 180 and prevents re-use of the lancet 140 regardless ofany re-arming and re-activating of lancet driver piston 180 by the user.

Although the preferred embodiments of the present invention have beendescribed herein, the above description is merely illustrative. Furthermodification of the invention herein disclosed will occur to thoseskilled in the respective arts and all such modifications are deemed tobe within the scope of the invention as defined by the appended claims.

What is claimed is:
 1. A single-use lancet cartridge for inserting intoa multi-use lancet driver assembly, the single-use lancet cartridgecomprising: an elongated lancet housing with an open end; a lancetwithin the lancet housing and movable between a retracted and restingorientation to a piercing orientation through the open end; and a re-useprevention component incorporated within the lancet cartridge andoriented to cooperatively engage with a driver piston of the multi-uselancet driver assembly external to the lancet cartridge only one timethereby preventing the lancet from being moved into a piercingorientation a second time, the re-use prevention component being arotatable drive wing having at least a first drive wing portion directlyconnected to a lancet body of the lancet and rotatable between a firstposition and a second position wherein the first position has the firstdrive wing portion extending laterally from a side of the lancet andwherein the second position has the first drive wing portion failing toextend beyond the side of the lancet, wherein when the first drive wingportion is in the first position the first drive wing portion ispresented for cooperative engagement with the driver piston and when inthe second position the first drive wing portion is incapable ofcooperative engagement with the driver piston.
 2. The single-use lancetcartridge of claim 1 wherein the rotatable drive wing has a second drivewing portion directly connected to the lancet body of the lancetopposite the first drive wing portion and rotatable between a firstposition and a second position wherein the first position has the seconddrive wing portion extending laterally from an opposite side of thelancet and wherein the second position has the second drive wing portionfailing to extend beyond the side of the lancet wherein when the seconddrive wing portion is in the first position the second drive wingportion is presented for cooperative engagement with the driver pistonand when in the second position the second drive wing portion isincapable of cooperative engagement with the driver piston.
 3. Thesingle use lancet cartridge of claim 2 further comprising ananti-rotation wing stop cooperatively engageable with the second drivewing portion.
 4. The single-use lancet cartridge of claim 1 furthercomprising a test strip integrally connected to the elongated lancethousing.
 5. A lancet system with safety feature, the system comprising:a multi-use lancet driver assembly having a driver piston, the multi-uselancet driver assembly contained within a meter housing; and asingle-use lancet cartridge having a lancet housing with an open end, alancet within the lancet housing and movable between a retracted andresting orientation to a piercing orientation through the open end, anda re-use prevention component incorporated within the lancet cartridgeand oriented to cooperatively engage with the driver piston of themulti-use lancet driver assembly only one time thereby preventing thelancet from being moved into a piercing orientation a second time, there-use prevention component being a rotatable drive wing having at leasta first drive wing portion directly connected to a lancet body of thelancet and rotatable between a first position and a second positionwherein the first position has the first drive wing portion extendinglaterally from a side of the lancet and wherein the second position hasthe first drive wing portion failing to extend beyond the side of thelancet, wherein when the first drive wing portion is in the firstposition the first drive wing portion is presented for cooperativeengagement with the driver piston and when in the second position thefirst drive wing portion is incapable of cooperative engagement with thedriver piston.
 6. The lancet system of claim 5 wherein the rotatabledrive wing has a second drive wing portion directly connected to thelancet body of the lancet opposite the first drive sing portion androtatable between a first position wherein the second drive wing portionextends laterally from an opposite side of the lancet and a secondposition wherein the second drive wing portion fails to extend beyondthe side of the lancet wherein when the second drive wing portion is inthe first position the second drive wing portion is presented forcooperative engagement with the driver piston and when in the secondposition the second drive wing portion is incapable of cooperativeengagement with the driver piston.
 7. The lancet system of claim 6further comprising an anti-rotation wing stop cooperatively engageablewith the first drive wing portion, the second drive wing portion orboth.
 8. The lancet system of claim 6 wherein the drive piston includesa deflectable drive wing pawl extending beyond the end of the drivepiston, the deflectable drive wing pawl having a wing rotating surfaceengageable with the rotatable drive wing after the lancet is moved intoa piercing orientation by the drive piston thereby causing the rotatablewing to rotate into the first elongated side opening.
 9. The lancetsystem of claim 5 further comprising a lancet cartridge lock within themeter housing, the lancet cartridge lock having an elongated and biasingmember with a locking tab extending laterally from the biasing memberand situated for cooperative and biasing engagement with a notch in thebottom of the lancet housing when a lancet cartridge is inserted into alancet cartridge receiving port of the meter housing.
 10. The lancetsystem of claim 5 further comprising a cartridge ejector having anejector body with a cartridge engaging member having a tab engagingsurface and a lancet cartridge ejector surface situated within the meterhousing, and an ejector button laterally and integrally connected to theejector body and disposed outside of the meter housing for slidablyejecting the lancet cartridge wherein the tab engaging surface ispositioned to engage the locking tab before the lancet cartridge ejectorsurface engages the lancet cartridge when the ejector button is slidablyengaged.
 11. The lancet system of claim 5 further comprising a piercingdepth control having an arcuate surface with a variable radius relativeto the piercing depth control axis that engages a piercing depth end ofthe arming member body situated within the meter housing and an outersurface a portion of which extends outside of the meter housing forsetting the position of the arcuate surface relative to the piercingdepth end of the arming member body.
 12. The lancet system of claim 5further comprising a scanner module housed within the meter housing andelectronically coupled to the electronic measuring module.
 13. Thelancet system of claim 5 wherein the lancet driver assembly furtherincludes an actuator button cooperatively connected to the driver pistonwhen the driver piston is in a cocked orientation.